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Completed

NCT Number: NCT05039567

Effect of an Optimal Heart Team Protocol on Decision-making Stability

This study is aimed to evaluate the effect of the optimal heart team implementation protocol on the stability of decision-making for patients with complex coronary artery disease.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

About this study

Current guidelines recommend a heart team in the decision making for patients with complex coronary artery disease (CAD). Previous study reported that the agreement between heart teams for revascularization decision-making in complex CAD patients was moderate. Potential factors associated with decision discrepancies were summarized in several aspects and a detailed heart team implementation protocol was generated and further validation is needed. This study is designed to evaluate the effect of the optimal heart team implementation protocol on the stability of decision-making for patients with complex coronary artery disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria for patients:

Inclusion criteria

Patients with stable CAD according to the National Cardiovascular Data Registry (NCDR) CathPCI criteria (stable angina, no or silent myocardial ischemia) and angiographically confirmed 3-vessel disease or left main disease.

Exclusion criteria

  • prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
  • cardiac troponin I (CTnI) greater than the local laboratory upper limit of normal or recent myocardial infarction with CTnI levels still elevated;
  • concomitant severe valvular disease, macrovascular disease, or huge ventricular aneurysm requiring surgery;
  • concomitant atrial fibrillation or severe arrhythmia

Eligibility Criteria for specialists:

Inclusion criteria

for interventional cardiologists:

  • Annual PCI volume ≥200
  • Annual left main PCI volume ≥25
  • Capable of chronic total occlusion(CTO) PCI
  • Clinical researcher experience in coronary revascularization
  • Proficient in clinical guidelines

Inclusion criteria

for cardiac surgeons:

  • CABG total volume ≥200
  • Proficient in both on-pump and off-pump CABG
  • Clinical researcher experience in coronary revascularization
  • Proficient in clinical guidelines

Inclusion criteria

for non-interventional cardiologists:

  • Proficient in clinical guidelines

Treatment and study plan

optimal heart team protocol

Behavioral

Heart teams in the experimental group will be established and trained based on the optimal heart team implementation protocol. The protocol included instructions on specialist selection, specialist training, team composition, team training and formal implementation precess.

Primary outcomes

  1. Overall percent agreement

    Time frame: through study completion, an average of 1 year

    The proportion of patients who received unanimous decision recommendations from the heart team

Secondary outcomes

  1. Kappa value of heart team decision-making

    Time frame: through study completion, an average of 1 year

    Fliess's (more than 2 raters) and Cohen's (2 raters) kappa coefficients to evaluate inter-team, inter-specialist, and inter-round agreement for treatment decisions.

  2. Inappropriate decision rate

    Time frame: through study completion, an average of 1 year

    According to the American College of Cardiology/American Association for Thoracic Surgery/American Heart Association 2017 Appropriate Use Criteria for coronary revascularization, the inappropriate decision rate od decision-making

  3. Compliance rate in real-world treatment

    Time frame: through study completion, an average of 1 year

    Compliance is defined as the patient's actual treatment meeting the recommendations of either heart team

  4. Reproducibility of decision-making

    Time frame: At 1-month after first phase of heart team meeting

    All cases will be discussed by the same heart team to evaluate the intra-team consistency in decision-making.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

The Effect of an Optimal Heart Team Implementation Protocol on the Stability of Decision-making for Complex Coronary Artery Disease-a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 9, 2021
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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